MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Implant date: exact implant date was not reported and was approximated to (b)(6) 2020.

Event Description

It was reported that the stent migrated.A 16x60mm, 100cm vici stent was selected for use in a procedure in (b)(6) 2020.The patient presented with a left-sided focal may-thurner syndrome blockage.The target lesion was approximately 30-40mm in length.Prior to stenting, a 0.035 inch non-boston scientific intravascular ultrasound (ivus) catheter was used to identify the blockage.The stent was sized 1:1, but a short size was selected.There were no difficulties during deployment.The stent was implanted in the left common iliac vein at the confluence.The stent appeared to fully expand and appose the vein walls.Several months later, the patient's symptoms recurred.On (b)(6) 2021, upon performing a venogram, the stent was not found in the location it was placed at confluence.Instead, the stent was discovered lodged in the left pulmonary artery.The patient was in stable condition.A follow-up stenting procedure was planned for a later date.

Event Description

It was reported that the stent migrated.A 16x60mm, 100cm vici stent was selected for use in a procedure in (b)(6) 2020.The patient presented with a left-sided focal may-thurner syndrome blockage.The target lesion was approximately 30-40mm in length.Prior to stenting, a 0.035 inch non-boston scientific intravascular ultrasound (ivus) catheter was used to identify the blockage.The stent was sized 1:1, but a short size was selected.There were no difficulties during deployment.The stent was implanted in the left common iliac vein at the confluence.The stent appeared to fully expand and appose the vein walls.Several months later, the patient's symptoms recurred.On (b)(6) 2021, upon performing a venogram, the stent was not found in the location it was placed at confluence.Instead, the stent was discovered lodged in the left pulmonary artery.The patient was in stable condition.A follow-up stenting procedure was planned for a later date.It was further reported that the initially implanted vici stent placed in the common iliac extended into the external iliac vein and proximally, was minimally protruding into the cava.The patient's lesion was re-treated with a non-boston scientific 18x100 stent during the follow up stenting procedure on an unknown date.

Manufacturer Narrative

D6a: implant date: exact implant date was not reported and was approximated to (b)(6) 2020.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11273998
• MDR Text Key: 230098454
• Report Number: 2134265-2021-01000
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/26/2021
• Removal/Correction Number: 92672766-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other